CLASS II · ModerateFDA

Medline Industries, LP recalls MEDLINE Medical Procedure Kits labeled as CH OPEN HEART

📅 May 4, 2026 · 📍 Nationwide

Recalling company: Medline Industries, LP
Product: MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Classification: Class II – may cause temporary or medically reversible health consequences
Recall date: May 4, 2026
Reported: Jun 24, 2026
Distribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Status: Ongoing
Quantity: 168968 units
Lot / codes: Medline Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each), 40193489344241 (case), Lot Number 21ABD933; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22IBJ338; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL456; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL231; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22BBW955; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22ABC123; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBM442; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBI539; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21FBT730; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21EBA066; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21CBW872; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBV936; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBL135; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617
Company location: Northfield, IL
Recall type: Voluntary: Firm initiated
Recall number: Z-2487-2026
Agency: U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2487-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.